Laboratory and Clinical Performance of the ADVIA Centaur Anticyclic Citrullinated Peptide Assay for Rheumatoid Arthritis Diagnosis.

Abstract

Anticyclic citrullinated peptide antibodies are important serologic markers for the diagnosis of rheumatoid arthritis. Several kinds of test reagents for automated immunoassay systems have been developed and used in recent years. To evaluate the analytic and diagnostic performance of the new ADVIA Centaur anticyclic citrullinated peptide assay (Siemens Healthineers, Erlangen, Germany) compared with the Elecsys assay (Roche Diagnostics, Mannheim, Germany). A total of 576 serum samples were collected from subjects, including 156 patients (27%) with rheumatoid arthritis. Precision performance and analytical measurement range for the ADVIA assay were evaluated. Diagnostic performance of the 2 assays was compared based on sensitivity, specificity, and area under the receiver operating characteristic curves. The ADVIA assay showed a within-laboratory imprecision of 3.4% coefficient of variation for levels of 3.36 and 24.99 U/mL. This assay was demonstrated to be linear from 0.4 to 180.0 U/mL. With default cutoff values, sensitivity and specificity for diagnosing rheumatoid arthritis were 71.2% and 97.9%, respectively, for the ADVIA assay and 73.1% and 96.9%, respectively, for the Elecsys assay. With the best cutoff values from the analyses of the receiver operating characteristic curve, the sensitivity of the 2 assays was the same at 75.6%. However, the specificity of the ADVIA assay was 96.4%, whereas that of the Elecsys assay was 94.3%. The area under the receiver operating characteristic curve value for the ADVIA assay was 0.867, which was not significantly different from that of the Elecsys assay (0.865). The ADVIA Centaur anticyclic citrullinated peptide assay showed good analytic and diagnostic performance in diagnosing rheumatoid arthritis.